U.S. Food & Drug Administration 10903 New Hampshire Avenue Do c ID# 0 4 0 1 7 . 0 2. 1 1 Silver Spring, MD 20993 www.fda.gov

July 16, 2018 Guangzhou Huafei Tongda Technology Co., Ltd. ℅ Ray Wang General Manager Beijing Believe-Med Technology Services Co., Ltd. Rm. 912, Building #15, Xi Yue Hui, No.5, Yi He North Rd. Fang Shan District Beijing, 102401 Cn Re: K181019

Trade/Device Name: Diode Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In

Dermatology Regulatory Class: Class II Product Code: GEX Dated: April 13, 2018 Received: April 17, 2018

Dear Ray Wang: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good

Page 2 - Ray Wang K181019

manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device EvaluationCenter for Devices and Radiological Health

Enclosure

Jennifer R. Stevenson -S3

6-1

K181019

510(k) Summary

7-1

Tab #7 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance

with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K181019

1. Date of Preparation

06/19/2018

2. Sponsor

Guangzhou Huafei Tongda Technology Co., Ltd.

4/F, Building B Industrial and Commercial Trading Park, Hainan Town, Huadi Dadao Nan

Road, Fangcun, Liwan District, Guangzhou 510388, P.R. China

Contact Person: Liu Pengqi

Position: General Manager

Tel: +86-13302285919

Fax: +86-20-81653065

Email: 179330082@qq.com

3. Submission Correspondent

Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd.,

FangShan District, BeiJing, China 102401

Tel: +86-18910677558

Fax: +86-10-56335780

Email: ray.wang@believe-med.com

510(k) Summary

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4. Identification of Proposed Device

Trade Name: Diode Laser System

Common Name: Powered Laser Surgical Instrument

Model(s): HF-108

Regulatory Information:

Classification Name: Powered Laser Surgical Instrument

Classification: II;

Product Code: GEX;

Regulation Number: 21 CFR 878.4810；

Review Panel: General & Plastic Surgery;

Intended Use:

The Diode Laser System is intended for hair removal, permanent hair reduction on all skin types

(Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs

regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

5. Device Description

The proposed device, Diode Laser System, is a surgical device, which is intended for hair removal,

permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

Function module description

a. Control Panel

The module uses the microcontroller as the heart, utilizes the LCD screen to display all prompt

information and the system state information to complete the human-machine interaction function,

and realizes the device parameters settings and accurate control of the output laser energy by the

operator.

b. Main Control Module

The module uses the microcontroller as the heart, receives the laser energy parameters and work

instructions from the control panel and detects the footswitch state; Utilizes the sensors of

temperature, humidity, liquid level and flow to detect the parameters such as temperature,

humidity and water flow during system working, and according to the detected values to calculate

the dew point temperature; Controls and detects the work state of constant current board module

as well as the temperature and humidity control system; Uploads the state data and alarm

information of water circulation system, cooling system, handpiece module and constant current

board module during system working.

c. Constant current board module

510(k) Summary

7-3

The module uses the high-power MOS as the heart, receives the laser energy parameters from the

main control module, supplies the semiconductor laser with constant drive current which

corresponding to the received laser energy parameters to drive the semiconductor laser to emit

light. The module also has the detection function of over-current, overvoltage, over-temperature

and handpiece state, and uploads the detected data to the control module.

d. Temperature and humidity control system

The system mainly includes the condenser, cold plate, water circulation subsystem and fans. The

microcontroller of main control module according to the temperature, humidity parameter detected

by the sensors to control the working state of the condenser, cold plate and cooling fan to meet the

temperature and humidity requirements during the semiconductor laser working.

e. Handpiece module

Handpiece module is the heart of the device, which is the execution unit of the device and

completes the laser emission function. The module is mainly composed of semiconductor laser,

sapphire, temperature and humidity sensor, data storage chips, cooling components and water flow

path. The semiconductor laser emits light to output energy, temperature and humidity sensors

detects the temperature and humidity parameters during handpiece working, the cooling

components and water flow path take away the heat of the semiconductor laser to prevent it from

being damaged caused by over-temperature, so prolongs the service life of the semiconductor

laser.

510(k) Summary

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6. Identification of Predicate Device

510(k) Number: K162659

Product Name: Diode Laser Hair Removal System

Manufacturer: Shandong Huamei Technology Co.,ltd.

510(k) Number: K142845

Product Name: SILKPRO Laser Hair Removal System

Manufacturer: Wuhan Lotuxs Technology Co., Ltd.

510(k) Number: K112031

Product Name: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with

Family of Soprano XLMulti-Application Platforms

Manufacturer: Alma Lasers, Inc.

510(k) Number: K153718

Product Name: Spirit Hair Removal Laser Family. Spirit-918/cFactor -918/mFactor-918

Manufacturer: Active Optical Systems Ltd.

7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as

was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the

proposed device complies with the following standards:

IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic

Safety And Essential Performance;

IEC 60601-2-22 Edition 3.1 2012-10, Medical Electrical Equipment - Part 2-22: Particular

Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic

And Diagnostic Laser Equipment.

IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and

requirements.

IEC 60601-1-2:2014 , Medical electrical equipment - Part 1-2: General requirements for basic

safety and essential performance - Collateral Standard: Electromagnetic disturbances -

Requirements and tests

ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5:

Tests For In Vitro Cytotoxicity. (Biocompatibility)

ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10:

Tests For Irritation And Skin Sensitization. (Biocompatibility)

Performance Testing for Spot Size Accuracy and Energy Output Accuracy.

8. Clinical Test Conclusion

510(k) Summary

7-5

No clinical study is included in this submission.

510(k) Summary

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9. Substantially Equivalent (SE) Comparison

Table 7-1 General Comparison

Item Proposed DevicePredicate Device

K162659

Predicate Device

K142845

Predicate Device

K112031

Predicate Device

K153718Remark

Product Code GEX GEX OHT GEX GEX SE

Regulation

Number21 CFR 878.4810 21 CFR 878.4810 21 CFR 878.4810 21 CFR 878.4810 21 CFR 878.4810 SE

Intended Use

The Diode Laser System is

intended for hair removal,

permanent hair reduction on

all skin types (Fitzpatrick

skin type I-VI), including

tanned skin.

Permanent hair reduction is

defined as the long-term,

stable reduction in the

number of hairs regrowing

when measured at 6, 9, and

12 months after the

completion of a treatment

regime.

The Diode Laser System is

intended for hair removal,

permanent hair reduction on

all skin types (Fitzpatrick skin

type I-VI), including tanned

skin.

Permanent hair reduction is

defined as the long-term,

stable reduction in the number

of hairs regrowing when

measured at 6, 9, and 12

months after the completion of

a treatment regime.

The SILKPRO is an

over-the-counter device intended

for adjunctive use with shaving

for hair removal sustained with

periodic treatments. SILKPRO is

also intended for permanent

reduction in hair regrowth

defined as a long-term, stable

reduction in hair counts

following a treatment regime.

permanent hair reduction is

defined as long term, stable

reduction in the number of hairs

regrowing when measured out to

6, 9, and 12 months after the

completion of the treatment

regimen

The Alma Lasers Family of Soprano

XL Multi-Application Platforms is

intended for use in dermatologic and

general surgical procedures.

The Alma Lasers Modified Diode

Laser Module (used with Alma

Lasers Family of Soprano XL

Multi-Application Platforms):

The HR modes is intended for hair

removal, permanent hair reduction.

The SHR Mode is intended for hair

removal, permanent hair reduction.

The LaserBlanche Mode is intended

for the treatment of benign vascular

and pigmented lesions.

The Alma Lasers Family of Soprano

XL Multi-Application Platforms is

intended for use on all skin types

The Spirit Hair Removal Laser

Family is generally intended for

dermatological use. The devices are

specifically indicated for hair

removal, permanent hair reduction

by using selective laser energy.

The Spirit Hair Removal Laser

Family is intended for use on all

skin types (Fitzpatrick skin types

I-VI), including tanned

skin.Permanent reduction in hair

regrowth is defined as long term,

stable reduction in the number of

hairs regrowing when measured out

to 6, 9, and 12 months after the

completion of the treatment regimen.

SE

510(k) Summary

7-7

(Fitzpatrick skin types I-VI),

including tanned skin.

Configuration

Main Unit Main Unit / Main Unit / SE

Handpiece Handpiece Handpiece Handpiece Handpiece SE

Foot Control Foot Control / Foot Control / SE

Principle of

OperationDiode Laser Diode Laser Diode Laser Diode Laser Diode Laser SE

510(k) Summary

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Table 7-2 Performance Comparison

Item Proposed DevicePredicate Device

K162659

Predicate Device

K142845

Predicate Device

K112031

Predicate Device

K153718Remark

Laser Type Diode Laser Diode Laser Diode Laser Diode Laser Diode Laser SE

Laser

ClassificationClass IV Class IV Class IV Class IV Class IV SE

Laser

Wavelength808 nm 808 nm 810 nm 810 nm 810 nm SE

Spot Size 1.20cm2 1.44 cm2 9 x 9 mm (0.81 cm2) 1.20cm2 12 x 16 mm (1.92 cm2) (Model 918) Discussion

Pulse

Duration30ms-200ms 5-400ms / 5-200ms (HR Mode); ≤ 20ms (SHR Mode) Up to 310 ms (Model 918) Discussion

Fluence 5-40 J/cm2 1-120J/ cm2 5 - 25J/ cm21-120J/ cm2 (HR Mode); ≤ 10 J/ cm2 (SHR Mode)

6-90 J/cm2 (Model 918) Discussion

Frequency 1-5Hz 0.5-15Hz / ≤ 3 Hz (HR Mode); ≤ 10 Hz (SHR Mode) ≤ 10 Hz (Model 918) Discussion

Power Supply 100-240V~ 50/60Hz AC 110V/60Hz / / / Discussion

Dimension510mm×600mm×

1000mm

450mm×

550mm×380mm/ / / Discussion

Weight 50Kg 52Kg / / / Discussion

Discussion

The proposed device has same indication for use with 4 predicate devices, the main differences are output parameters, such as spot size, fluence, frequency range, pulse

duration.

For these output parameters, the Fluence and Pulse duration are most important parameters which may decides that how much and how long time the energy will deliver to

510(k) Summary

7-9

the patient’s skin, it may effects the safety (too much energy and/or too long action time) may burn patient’s skin, and effectiveness (too low energy and/or too short action

time) may make the device could not achieve it’s indication for use.

From the comparison above, the fluence of proposed device is 5-40 J/cm2, the fluence of predicate device are 1-120J/ cm2, 5 - 25J/ cm2, ≤ 10 J/ cm2, and 6-90 J/cm2.They are not exactly same, but the fluence of proposed device is covered or limited the fluence of predicate device. Because the maximum fluence of proposed are lower

than some predicate device (120 J/cm2, 90J/cm2), it can be considered as the proposed device has acceptable safety; and the maximum fluence of proposed are higher than

some predicate device (25J/ cm2, 10 J/ cm2), it can be considered as the proposed device has capable to achieve it’s indication for use. The Pulse duration of proposed

device is 30 ms -200 ms, which is similar with the predicate device, and it is also covered or limited the pulse duration of predicate device, which is longer or same than

some predicate device (200 ms, 400 ms, 310 ms), and less than some predicate device (20 ms), so same reason as fluence, the pulse duration of proposed device has

acceptable safety and has capable to achieve it’s indication for use.

As the justification above, the difference of pulse duration and fluence ranges does not affect the safety or effectiveness of proposed device for it’s indications for use.

510(k) Summary

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Table 7-3 Safety Comparison

Item Proposed DevicePredicate Device

K162659

Predicate Device

K142845

Predicate Device

K112031

Predicate Device

K153718Remark

Patient Contact Materials and Biocompatibility

Patient Contact

Materials

Sapphire and aluminum alloy in

handpieceSapphire in handpiece Discussion

Cytotoxicity No Cytotoxicity No Cytotoxicity

SESensitization No evidence of sensitization No evidence of sensitization

Irritation No evidence of irritation No evidence of irritation

EMC, Electrical and Laser Safety

Electrical SafetyComply with IEC 60601-1, IEC

60601-2-22Comply with IEC 60601-1, IEC 60601-2-22 SE

EMC Comply with IEC 60601-1-2 Comply with IEC 60601-1-2 SE

Laser SafetyComply with IEC 60601-2-22, IEC

60825Comply with IEC 60601-2-22, IEC 60825 SE

Discussion

The proposed device is different in Patient Contact Materials from the predicate device. but both the predicate device and the proposed device has passed the ISO10993

series test, we believe these differences will not affect the effectiveness and safety compared with the predicate device., the proposed device is determined to be

substantially equivalency with predicate device.

510(k) Summary

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10. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially

Equivalent (SE) to the predicate device.